Training for Persons With Complete SCI for FES Cycling: a Case Series

Spinal Cord Injuries Clinical Trial

Official title:

Training of Persons With Complete Spinal Cord Injury for Pedaling on a Tricycle, Induced by Electrical Stimulation of the Paralysed Muscles: a Case Series

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04412447
• Other study ID #: 2019-A00808-49
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: September 2020

Study information

• Verified date: June 2020
• Source: Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to validate the effectivity of a simple home-based training for cycling with functional electrical stimulation (FES). The training is designed to progressively increase strength and endurance of the paralysed muscles of a person with complete spinal cord injury. After a limited period of only several months, performance will be assessed during FES-assisted cycling on a recumbent tricycle over flat ground. The outcomes of this study should provide evidence for the effectivity of FES-cycling as potential rehabilitation method.

Description:

People with spinal cord injuries suffer from numerous comorbidities, linked in particular to immobility and sedentariness. Studies have shown the benefits of training and reconditioning to adapted effort in spinal cord injured people. Among other innovative techniques, functional electrical stimulation (FES) is aimed primarily at mobilizing as many muscles as possible. Concerning electro-stimulated pedaling on a tricycle, it would allow individuals with paraplegia or tetraplegia to practise physical activity in perspective of experiencing pleasure during training.

In 2016, our team carried out a pilot study aiming at using a recumbent tricylce powered by the lower limbs of a person with complete paraplegia under electrostimulation. The participant was trained for 12 months, whit the objective to participate at an international competition (Cybathlon 2016). This first study has opened up prospects and identified avenues for improvement.

The main objective of this study is to significantly improve, over a limited period of time, the pedalling performance on a tricycle by using electrical stimulation of the sub-lesional muscles of people with spinal cord injuries. Secondary focusses will be: physical and psychological tolerance to training; influence on pain, cardio-respiratory functions, body composition regarding muscle trophicity and bone metabolism; psycho-social impact; impact of modification of stimulation parameters (frequency, phase width, intensity, waveform, contact location) in performance optimization and delay of muscle fatigue; performance impact of mechanical modifications performed on the tricycle.

This is a prospective case study: patients suffering from a complete traumatic injury and followed at the Centre de Rééducation et de Réadaptation Fonctionnelle (CRRF) La Châtaigneraie (Menucourt) will be recruited by the investigating physician during a consultation for a period of approximately 6 months. The centre specialised in the management of acute and chronic neurological lesions. The eligibility criteria are predefined to ensure the participants safety. After verification of the criteria and before the start of the programme, an exercise test (monitoring of the evolution of VO2max) will be carried out in the Sports Medicine department of the CHI of Saint-Germain-en-Laye. The first phase (V1) consists of a one-month home-based isometric muscle training programme by electrostimulation followed by a two-month programme (phase V2) of home-based muscle training by electrostimulation on an ergocycle including one training per week at the CRRF. The home ergocycle electro-stimulation muscle training, will be continued once or twice a week and complemented in the third phase (V3) by training at the CRRF on a tricycle for one month. Only the patient selected to participate in the Cybathlon 2020 will continue with the final phase (V4), which includes, over a period of 2 to 4 months, muscle training by electrostimulation on an ergocycle at home, electrostimulation sessions on a tricycle up to 3 times a week at the CRRF. In this phase, the optimization of the stimulation and electrical patterns and the mechanics of the tricycle will take place in order to maximize the pilots overall performance. Finally, the pilot will take part in the tricycle FES-Cycling race at the Cybathlon 2020 in Zurich, i.e. an international competition and technological challenge, requiring to master 1200 metres in a maximum time of 8 minutes. The different training programs are based on sport-scientific principles and a physiotherapist will follow up on the home sessions. The collaborating teams (engineers and researchers from INRIA, the French National Institute for Research in Computer Science and Control) will measure performance in a bimonthly frequency.

This research should demonstrate that the safety, acceptability, satisfaction, self-esteem and quality of life induced by the practice of FES-assisted pedalling, opens a new way of training in rehabilitation centres and at home with the perspective of improving certain physiological functions in the long-term.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2
• Est. completion date: September 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• informed written consent

• complete spinal cord injury AIS A or B

• neurological level of lesion C6 - T12

• post-lesion duration > 12 moths

• paralysed muscles stimulable

• joints of lower limb freely moveable

• stable medical condition (absence of infectious respiratory or urinary event of cutaneous pathology confining the patient to bed and warranting treatment).

Exclusion Criteria:

• Not affiliated to a social security scheme, beneficiary or not such a plan

• Refusal to participate in the study (withdraw from study possible at any time)

• Inability to give consent

• body mass index higher or equal to 30

• flaccid paralysis (denervation)

• Inability to give consent

• neurogenic para-osteoarthropathy

• active thrombophlebitis

• muscular disease

• cardiovascular disease including coronary antecedent

• bone mineral density T-score below -2.5

• treatment with a drug known to have an effect on bone (< 3 months)

• Aids in the lower limbs

• Epilepsy

• Orthostatic hypotension

• Fractures of the lower limbs older (< 12 months)

• Pacemakers or other implants contraindicating the use of FES

• Pregnancy (women)

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

Device:
• Functional Electrical Stimulation
Electrical stimulation of motor-nerves innervating the musculature of the lower limb.

Locations

Country	Name	City	State
France	Centre de Rééducation et de Réadaptation Fonctionnelle La Châtaigneraie	Menucourt

Sponsors (3)

Lead Sponsor	Collaborator
Centre de Rééducation et Réadaptation Fonctionnelle La Châtaigneraie	Institut National de Recherche en Informatique et en Automatique, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maximum Cycling-Distance in [m]	Change in maximum distance cycled on flat ground on a tricycle	Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Primary	Change in Maximum Cycling-Speed in [km/h]	Change in maximum speed during cycling over flat ground on a tricycle	Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Primary	Change in Average Cycling-Speed in [km/h]	Change in average speed during cycling over flat ground on a tricycle	Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Primary	Change in Maximum Cycling-duration in [hh:mm:ss]	Change in maximum duration during cycling over flat ground on a tricycle	Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Primary	Change in Maximum Pedaling-Cadence in [RPM]	Change in maximum pedaling-cadence during cycling over flat ground on a tricycle	Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Primary	Change in Average Pedaling-Cadence in [RPM]	Change in average pedaling-cadence during cycling over flat ground on a tricycle	Change between 4 months of training (end of V3) and 6 months of training (end of V4)
Primary	Ability to cycle 1200m in less than 8min	Qualification criterion Cybathlon 2020. It will be assessed it the pilot is able to cycle 1200m in less than 8min over flat ground on a tricycle.	After 6 months of training (end of V4)
Secondary	Change of blood pressure during training	Blood pressure will be assessed before and after every training session. Mean change in blood pressure will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration
Secondary	Change of heart rate during training	Heart rate will be assessed before and after every training session. Mean change in heart-rate will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration
Secondary	Maximum heart rate during training	Maximum heart rate will be assessed during every training session. Mean and SD of the maximum heart-rate will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration
Secondary	Average heart rate during training	Average heart rate will be assessed during every training session. Mean and SD of the average heart-rate will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration
Secondary	Cutaneous status	Evaluation for absence of: skin lesions, pressure points, pressure ulcers, phlebitis, edema	through study completion (up to one year)
Secondary	Musculo-skeletal pain or inflammation	Evaluation for absence of: muscular pain, osteo-articular pain or inflammation	through study completion (up to one year)
Secondary	Psychological: Satisfaction	Evaluation of satisfaction [linear scale: 1 - 10; 1 = lowest satisfaction; 10 = highest satisfaction] will be assessed after every training session. Mean and SD of the satisfaction will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration
Secondary	Psychological: Acceptability	Change in acceptability [questionnaire].	through study completion (up to one year), every 30 days
Secondary	General Fatigue	Assessment of change in general fatigue via [Borg scale; Range: 6-20; 6 = No exertion, sitting and resting; 20 = Maximal exertion] will be assessed before and after every training session. Mean and SD of the change in fatigue will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration
Secondary	Psycho-Social: Self-Esteem	Change in self-esteem via [Rosenberg Scale; Range: 10 - 40; 10 = lowest Self-Esteem; 40= Highest Self-Esteem].	through study completion (up to one year), every 15 days
Secondary	Psycho-Social: Quality of Life	Change in quality-of-life via [questionnaire SF-36].	through study completion (up to one year), every 30 days
Secondary	Cardio-Respiratory Fitness: Maximal Heartrate	Change of maximal heartrate via electrocardiogram	Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
Secondary	Cardio-Respiratory Fitness: VO2max	Change of VO2max	Change between timepoint before first training, after 4 months of training (end of V3) and after 6 months of training (end of V4)
Secondary	Musculo-skeletal changes: Thigh perimeter	Assessment of thigh perimeter [cm]. Measurement is taken 10cm and 20cm proximal to the proximal edge of the patella.	Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Secondary	Musculo-skeletal changes: Bone mineral density	Bone mineral density via [DEXA]	Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Secondary	Musculo-skeletal changes: Body composition	Body composition via [DEXA].	Change between timepoint before first training and after end of study (end of V5, ~ 7 months)
Secondary	Occurrence of spasms: before training	Spasmic occurance will be assessed via [PENN Scale; Range: 0-4; 0 = No spasm; 4 = Spasms occuring more than 10 times per hour] before every training session. Mean and SD of the spasmic occurence will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration
Secondary	Occurrence of spasms : after training	Spasmic occurance will be assessed via [PENN Scale; Range: 0-4; 0 = No spasm; 4 = Spasms occuring more than 10 times per hour] after every training session. Mean and SD of the spasmic occurence will be calculated along all training-sessions.	through study completion (up to one year), an average throughout the study-duration